- Reviewing ingredients for regulatory compliance for different markets and product categories.
- Provide comprehensive regulatory assessments for ingredients, new products, and reformulations using appropriate databases.
- Partner with manufacturers and ingredient suppliers to acquire all necessary documentation to maintain an accurate library of robust products and raw materials.
- Prepare, compile, and organize all relevant documentation for product registrations and listings.
- Ensure renewals for state licenses.
- Maintain business systems, databases, and knowledge sharing systems as appropriate.
- Coordinate FDA Drug Listing submissions for Rx and OTC products under supervision from Regulatory and Quality Leadership
- Initiate change controls in Ensur QMS system as required.
- Manage purchase orders (POs) for the regulatory department.
- Ensure appropriate follow-up correspondence, such as re-submissions, re-certifications, renewals as required.
- Other duties as assigned by the Supervisor.
- A high school diploma is required; a bachelor's degree from an accredited university with a focus in Life Sciences; Chemistry highly preferred.
- At least 2-3+ years of relevant experience within regulatory affairs; familiarity with regulatory frameworks across various jurisdictions and a keen ability to accurately interpret and apply them real time.
- Exceptional organizational and prioritization/time management skills; demonstrated ability to work under pressure to meet deadlines.
- Comfortable operating in a fast paced, ever-changing environment; someone who thrives in ambiguity and adapts quickly.
- Proficiency in Microsoft Office and other technologies.
- An energetic, positive attitude that encourages a team and supports the growth and professional development of others.
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Regulatory Affairs Associate - Long Beach, United States - OBAGI COSMECEUTICAL LLC
Description
Job Description
Job DescriptionWho We Are:
Obagi Cosmeceuticals is an industry leading, ~$120M dermo-cosmetic brand that provides transformational skin care products clinically formulated to minimize signs of skin aging, address dark spots, hyperpigmentation, fine lines, and wrinkles. A 35-year legacy backed by science and innovation to protect and enhance skin tone and texture. Ranked No. 1 and widely recognized by US dermatologists and plastic surgeons for its clinical excellence and science-backed approach, Obagi remains a leader in the beauty space and operates as an innovative, global, omni-channel luxury consumer products business with sales distribution to physicians, wholesale partners, retail outlets, Amazon, and direct-to-consumer (DTC) channels. On a mission to create a global, best-in-class multi-brand, multicategory portfolio, Obagi will continue to redefine the future of skincare. We are Obagi. Fearless. Together.
What We Need:
Obagi is seeking a reliable and meticulous Regulatory Affairs Associate to organize, manage, and maintain files in our database/platform. This person will play a key role in ensuring that all files adhere to regulatory and compliance requirements across the jurisdictions where our operations extend.
What You'll Do:
What You'll Need:
Physical Requirements:
These demands document the physical requirements of a specific job. Criteria may include: Lifting, Carrying, Push/Pull, Sitting/Standing (In Place); On Feet, Walking, Bending, Turn/Twist; Kneeling; Squatting; Crawling; Climbing; Reaching (Out)/Reaching (Up), Grasping, Wrist Turning; Pinching; Finger Manipulation, Hearing, Talking, Working with a computer for eight hours, Working in close quarters. Communicating over the telephone for eight hours.
Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of job requirements, so classified. All employees may be required to perform duties outside of their normal responsibilities, from time to time, as needed.
